Completed

Phase 2
Age: 18Years +
All Genders
ID05498181

Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation

Led by Brigham and Women's Hospital · Updated on 2026-06-08

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.

CONDITIONS

Brief Title

Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults ≥18 years initiating HD (within 90 days of first HD session)
  • Thrice-weekly HD
  • Informed consent
  • Hemodynamically Stable: Sitting pre-dialysis SBP ≥110 mmHg averaged over prior two weeks or at the baseline visit; no symptomatic hypotension in prior two weeks; no use of midodrine.
  • Has not taken an ACEi for 36 hours prior to randomization
Not Eligible

You will not qualify if you...

  • Anuria (daily urine volume <100 mL/day)
  • Current or any use of sacubitril/valsartan within the past 30 days
  • History of hypersensitivity or intolerance to any of the study drugs, including ARBs or sacubitril/valsartan
  • Angioedema related to previous ACE inhibitor, ARB, or ARNI therapy
  • Serum potassium >5.5 mEq/L at screening (pre-HD if already on HD)
  • Acute coronary syndrome, stroke, TIA, major CV surgery, percutaneous coronary intervention or carotid angioplasty within one month
  • Intended coronary or carotid revascularization within 4 months
  • Implantation of a cardiac resynchronization therapy device (CRTD) within 3 months or intent to implant a CRTD
  • History of heart transplant, or planned heart transplant, or with left ventricular assist device
  • Planned renal transplant within 4 months
  • Documented untreated ventricular arrhythmia with syncopal episodes within 3 months
  • Symptomatic bradycardia or 2nd or 3rd degree heart block without a pacemaker
  • Presence of hemodynamically significant valvular disease or hypertrophic cardiomyopathy or infiltrative cardiomyopathy including suspected or confirmed amyloid heart disease (amyloidosis)
  • History of malignancy of any organ system within the past year (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
  • Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis with evidence of portal hypertension); Alanine aminotransferase (ALT) levels >2.0 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN, unless consistent with Gilbert's disease
  • Pregnant (positive hCG test) or lactating women
  • Enrollment in another interventional trial
  • Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline
  • Does not have capacity to consent (Folstein mini-mental score of 23 or less)
  • Any condition that in the opinion of the investigator would make participation not in the best interest of the subject
  • Women of child-bearing age, unless using two birth control methods. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of investigational drug and for 7 days off of study drug.

Trial Site Locations

Total: 1 location

1

Brigham and Women's

Boston, Massachusetts, United States, 02115

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Angiotensin-Neprilysin Inhibition and Renal Outcomes in Heart Failure With Preserved Ejection Fraction.

Finnian R Mc Causland, Martin P Lefkowitz, Brian Claggett...

https://pubmed.ncbi.nlm.nih.gov/32845715